Safety Issues in Computerized Medical Equipment

Author(s):  
D. John Doyle

Computers now are being used increasingly in safety-critical systems like nuclear power plants and aircraft and, as a consequence, have occasionally been involved in deadly mishaps. As microcomputer technology continues to proliferate, computers are also now increasingly being used in medical equipment such as ventilators and pacemakers, sometimes with safety-critical results. This chapter discusses some of the special concerns that arise when computer technology is introduced into medical equipment, using two case studies as examples: the Therac-25 radiation therapy unit and Abbott’s patient controlled analgesia machine. Also discussed are some of the regulations that have been proposed by the (American) Food and Drug Administration (FDA) to help tackle the special problems that can arise when developing software-based medical equipment.

2017 ◽  
Author(s):  
Christian Motika

Safety-critical systems are a subclass of reactive systems, a dominating class of computer systems these days. Such systems control the airbags in our cars, the flaps of an aircraft, nuclear power plants or pace makers. Software for these systems must be reliable. Hence, a language and tooling is needed that allows to build and maintain reliable software models. Furthermore, a reliable compiler is required to obtain decent machine-understandable and executable code from highly abstract models. This thesis presents SCCharts, a Statecharts-based synchronous and visual modeling language for specifying and designing safety-critical systems and for deriving their implementations. It elaborates on why a control-flow oriented and synchronous language is desirable and how incremental language features are chosen to flatten learning curve. It presents an interactive incremental model transformation based compilation approach termed SLIC. It shows how SLIC helps in supporting both, the modeler and the tool smith for building reliable models and maintaining a reliable compiler, respectively. A SLIC-based compiler for SCCharts including its high-level model transformations is presented. Furthermore, practicality aspects of the KIELER SCCharts language and tooling implementation complete the considerations to validate the proposed approach.


2017 ◽  
Author(s):  
Christian Motika

Safety-critical systems are a subclass of reactive systems, a dominating class of computer systems these days. Such systems control the airbags in our cars, the flaps of an aircraft, nuclear power plants or pace makers. Software for these systems must be reliable. Hence, a language and tooling is needed that allows to build and maintain reliable software models. Furthermore, a reliable compiler is required to obtain decent machine-understandable and executable code from highly abstract models. This thesis presents SCCharts, a Statecharts-based synchronous and visual modeling language for specifying and designing safety-critical systems and for deriving their implementations. It elaborates on why a control-flow oriented and synchronous language is desirable and how incremental language features are chosen to flatten learning curve. It presents an interactive incremental model transformation based compilation approach termed SLIC. It shows how SLIC helps in supporting both, the modeler and the tool smith for building reliable models and maintaining a reliable compiler, respectively. A SLIC-based compiler for SCCharts including its high-level model transformations is presented. Furthermore, practicality aspects of the KIELER SCCharts language and tooling implementation complete the considerations to validate the proposed approach.


Author(s):  
Andriy Kovalenko ◽  
Ievgen Babeshko ◽  
Viktor Tokarev ◽  
Kostiantyn Leontiiev

This chapter describes an element base of new generation for NPP I&C, namely field programmable gate array (FPGA), and peculiarities of the FPGA application for designing safety critical systems. FPGA chips are modern complex electronic components that have been applied in nuclear power plants (NPPs) instrumentation and control systems (I&CSs) during the last 15-17 years. The advantages and some risks caused by application of the FPGA technology are analyzed. Safety assessment techniques of FPGA-based I&CSs and experience of their creation are described. The FPGA-based platform RadICS and its application for development of NPP I&CS is described.


Author(s):  
D. John Doyle

Alarms are frequently employed in safety-critical environments such as in aviation and nuclear power plants. Now that microcomputer technology has revolutionized the design of patient monitors for use in modern hospital operating rooms (ORs) and intensive care units (ICUs), alarms are used in countless medical products ranging from infusion pumps to ventilators. This is especially true in anesthesia/surgical and critical care environments. In this chapter we examine the use of alarms in the acute care clinical environment, focusing on their strengths and limitations in the setting of patient monitoring equipment.


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